The global presence of drugs of abuse continues to expand. In 2014, approximately 144 tons of amphetamine class narcotics were seized globally. Cannabis plant material in 2012 was estimated at 5,350 tons, with an additional 1,269 tons of Cannabis resin seized.[1] Opiates type stimulants account for most drug related disease and deaths worldwide. Globally, most regions have seen increased opium poppy cultivation. An emerging phenomenon among opioid-dependent drug users in the United States of America is that synthetic opioids are being replaced with heroin.[2] Seizures of Cocanie have increased from 634 tons to 671 tons between 2011 and 2012. The most problematic use of cocaine is in the Americas, with an increase in prevalence recently observed in the United States.[3] North America accounted for half of all of these seizures, with the remainder spread throughout the world.[1] New regulations in the United States, specifically Colorado and Washington, allow legal Cannabis production, supply and recreational use. It remains to be seen what impact these regulatory changes will have and adding to the uncertainty is an influx in the number of synthetic un-regulated narcotics and novelties such as edible cannabis candies.[2] Globally, drugs of abuse remain an ever present threat in all sectors of society. Clearly, there is a ready need for low cost, mass producible, test kits for rapid identification of said drugs of abuse.
Most commercially available presumptive narcotic test devices and available IP and literature, use and describe methods which contain hazardous materials and sophisticated packaging which are not suitable for extremely cheap mass production in simple factory settings.
By way of example, prior art commercially available presumptive narcotic test kits include: NIK® Presumptive Drug Tests, ODV™ Narcopouch® Presumptive Drug Tests, Field Forensics DABIT® Presumptive Drugs Tests, DanceSafe Test Kits, EzTest Australia, D4D (MD-1) and C&H (MD-2), Mistral PDT and Aerosol Drug Tests.
These narcotic test kits suffer from a variety of manufacture and end use problems, including but not limited to: (i) kit construction requires liquid dropper bottles, breakable glass or plastic ampoules, blister packs and pressurized aerosol spray cans filled with hazardous liquid reagents; (ii) the presence of hazardous liquid reagents poses problems with manufacturing and exposure limitations, storage and handling, strict packaging requirements and significant shipping restrictions; (iii) the volume or quantity of liquid reagent consumed during one single test is excessive and wasteful adding to costly, bulky and often overly complicated device construction design and packaging; (iv) during use, operators may be exposed to sharps and hazardous liquid reagent splash or overspray; (v) most prior art devices require multi-step operations in order to complete a single test; and (vi) none of the prior art kits and devices achieve the bench mark of true low cost mass manufacturing, which would be considered in the range of tens of millions of individual units per annum, with a commercial shelf life span of 2 to 3 years.
As pointed out, there are many methods of presenting kits for presumptive identification of Amphetamine, Cannabis, Cocaine, Heroin, as well as intellectual property and public domain literature. Most however do not also claim detection and identification of selected synthetic Cannabinoid and amphetamine based Cathinone type stimulants and cannabis consumable products. Without limitation and by way of example only, a relevant selection of this literature is presented.
United Nations Office on Drugs and Crime publication(s) [4] and Zakrzewska, A., et al. [5] describe the use of diazonium salts (e.g. Fast Black K salt) dissolved in organic solvents for visualization of Amphetamine type stimulants when sprayed onto developed TLC plates.
U.S. Pat. No. 8,124,420 discloses a method for broad drugs of abuse screening and identification utilizing two separate colorimetric test devices. The first device utilizes diazonium salts (e.g. Fast Corinth V and Fast Black K salts) for the identification of Amphetamine and Cannabis type stimulants. The diazonium salts are prepared by sophisticated laboratory procedures and then packaged in breakable ampoules in combination with additional sealed ampoules of organic solvents (e.g. Methylene chloride or DMSO). A suspect residue obtained with an additional sophisticated multi-layer swab paper is added to the two ampoules in a container of sorts, the ampoules must be broken and all ingredients mixed together to produce a color indication. Many problems exist with this particular system: the methylene chloride is a hazardous and flammable organic solvent; DMSO, if used and presented alone as disclosed, will, in most working environments freeze and prevent the kit from functioning; the diazonium salt powder as disclosed requires sophisticated laboratory equipment and reagents for preparation and very sophisticated temperature and ambient gas-controlled ampoule sealing equipment to prevent contamination during diazonium powder packaging; the quantity of diazonium salt and organic solvent required for one single test is very costly and wasteful; the overall disclosure is not suitable for low cost, single unit, mass production.
U.S. Pat. No. 3,713,779, U.S. Pat. No. 3,748,098 and U.S. Pat. No. 7,384,599, disclose colorimetric test kits which consist of breakable ampoules filled with hazardous liquid reagents. U.S. Pat. App. No. 20150017732 discloses a similar test kit for the detection of Amphetamines, Opiates, synthetic Cannabinoids and Cathinones, wherein the kit consists of ampoules filled with known hazardous liquid reagents including, but not limited to, Dragendorf, Simons, Scott's and Marquis reagents. Additional ampoules are filled with solutions of methyl orange, xylenol orange, calmagite, FD&C blue 1, metanil yellow, 1-(2-hydroxyl-1-naphthylazo)-2-naphthol-4-sulfonic acid zinc salt, 3-((E)-(4-((E)-(4-amino-7-sulfonatonaphthalen-1-yl)diazenyl)-7-sulfonatonaphthalen-1-yl)diazenyl)naphthalene-1,5-disulfonate sodium salt, 2-((4-hydroxyphenyl)(4-oxocyclohexa-2,5-dien-1-ylidene)methyl)benzenesulfonate sodium salt, or 4-((E)-(4-(ethylamino)-3-methylphenyl)((E)-4-(ethylimino)cyclohexa-2,5-dien-1-ylidene)methyl)-3-sulfobenzenesulfonate sodium salt.
A further example of alternative packaging methods to provide a useable colorimetric test kit is disclosed in U.S. Pat. No. 4,965,047 and U.S. Pat. No. 4,196,167 which describe blister pack devices filled with solutions of hazardous reagents which change color in the presence of Cannabis type stimulants. Blister packaging requires both sophisticated industrial equipment for dispensing aliquots of liquid reagents into, and sealing blisters or pressure sensitive adhesive closure films. The quantity of reagent used per blister test is excessive. This device construction is also not suitable for mass manufacture of low cost individual test kits.
Yet another method for packaging sensitive reagents to increase shelf life is disclosed in U.S. Pat. No. 4,771,005 which describes a device for Marijuana detection consisting of pressurized spray cans filled with diazonium salt solutions including: Fast Blue B salt, Fast Garnet, Fast Red, Fast Corinth V, Fast Blue BB.
U.S. Pat. No. 7,374,946 and U.S. Pat. App. No. 20050130312 disclose a method for the presumptive identification of Amphetamine type stimulants based on time of color development when reacted with mineral acids of varying concentration and applied heat. The disclosed method requires hazardous and corrosive liquids and heating equipment, in a laboratory setting.
U.S. Pat. No. 4,288,344 discloses a method for improving the shelf life of a diazonium salt by instantaneous generation of said diazonium salt with precursor reagents dissolved in methyl cellosolve, which can react in the presence of Cannabinoids to produce a characteristic colored product. Here again, the disclosed method requires highly toxic solvents and solutions and bulky sophisticated packaging and reaction vessels.
Many bibulous carrier kits, pre-impregnated with Amphetamine and Cannabis type stimulant color change reagents are known. U.S. Pat. No. 5,523,051, U.S. Pat. No. 4,752,448 and WO1984002397A1 disclose bibulous carriers impregnated with Dragendorf and Chloroplatinic acid reagents. Although the Dragendorf reagent is capable of being dried into a bibulous carrier, the disclosure has not explained how to overcome the presence of concentrated hydrochloric acid in a standard Dragendorf reagent mixture. Without replacing this reagent with a suitable alternative, removal of concentrated acid fume is very complicated. False positive indications are frequent with these presumptive reagents due to the broad spectrum nature of color detection which reduces the suitability of this kit type for use in law enforcement. U.S. Pat. App. No. 20120295362 discloses a Marquis reagent impregnated paper strip, with a foil protective layer. In its disclosed form, this kit is unlikely to function well, as the concentrated sulphuric acid, will likely char and destroy most bibulous carrier materials within minutes and rapidly dissolve the foil protective layer. Any remaining unreacted formaldehyde would most likely evaporate. World Pat. No. 1989009395 A1 discloses a bibulous carrier strip impregnated with a diazonium salt in combination with zinc chloride. In its disclosed form, this kit is unlikely to achieve suitable commercial shelf life requirements of 2-3 years, as the diazonium salt, being extremely sensitive to ambient oxidation, hydrolysis and UV degradation will be rendered un-viable in a matter of days. The hygroscopic properties of the zinc chloride would likely increase ambient moisture content within the bibulous carrier, catalyzing breakdown of the diazonium salt. U.S. Pat. No. 3,915,639 discloses bibulous carrier strips into which ion exchange resin powders, loaded with Dragendorf, Ninhydrin and Sodium sulphate color change reagents, with the addition of color intensifying hydrazine reagent(s), are absorbed. The strips are for biological fluid analysis. As an example, this disclosure describes a weakly alkaline amine-type ion-exchange resin which is to be loaded with an acidic solution of Dragendorf reagent. The difference in pH of both components is not complimentary and post drying to a powdered product, would jeopardize the long term viability. It is likely that this mixture would remain wet, complicating subsequent manufacturing steps. Also described is the addition of color intensifying hydrazine reagents, for example di-nitro-phenyl hydrazine which is a hazardous, shock and friction explosive, not ideal for storage, shipping, packaging and handling. Further, the presence of the amine groups, both in the exchange resin and color intensifying agent, are likely to react with the Dragendorf reagent, providing false positive indications. U.S. Pat. No. 4,816,415 and U.S. Pat. No. 4,806,487 disclose a method to pre-concentrate marijuana from biological fluids into suitable papers and then visualize the papers with diazonium salt solutions including: Fast Blue BB salt, Fast Green salt, and Fast Bourdeaux Gp.
United Nations Office on Drugs and Crime publication [6] describes the use of liquid solution of Ferric sulphate (5 g dissolved in 100 mL water) for presumptive identification of Opium, Codeine, Morphine and Heroin type stimulants. A small sample of suspect residue is placed onto white test plate, dissolved, with mixing in few drops of water and then a few drop of the Ferric sulphate solution added, with mixing, to produce a typical dark brown/purple indication. Also described is the use of Mecke, Marquis and Nitric acid liquid reagents, with identical procedure.
United Nations Office on Drugs and Crime publication [3] describes the use of Marquis, Frohde and Mecke reagent solutions for presumptive identification of Opium, Morphine and Heroin type stimulants. The procedure is very much designed for laboratory settings and requires equipment, sample preparation and workup prior to addition of the colorimetric reagents and presumptive identification.
U.S. Pat. No. 3,955,926 discloses a method for broad drugs of abuse screening and identification. Opium is identified by preparing a bibulous carrier with dry impregnated Ferric ammonium sulphate, dissolving suspect residue in acetic acid, utilizing bench mounted equipment, then immersing the dry impregnated carrier into the acid solution facilitating a presumptive color indication. In the disclosed format it is not apparent how the dry carrier, impregnated with a hygroscopic ferric salt, will remain dry and functional for long period of time. In the disclosure, both Morphine and Heroin detection requires Ferric chloride salt and acidified solutions of Iodic acid. Both these reagents simply cannot be utilized in dry solid support carrier format, as in the current invention. These salts are far too sensitive, rendered inactive within hours, once exposed to ambient conditions.
U.S. Pat. No. 4,110,078 discloses a method for a highly specific colorimetric method for detecting the presence of opium and heroin in a sample, which comprises sample collection, dissolution in liquid halogenated hydrocarbon, shaking this organic phase with aqueous chloroplatinic acid in aqueous solution and subsequent addition of aqueous cobaltous thiocyanate in aqueous solution, followed by the development of a presumptive color indication in said organic phase. Again, this disclosure requires a laboratory setting, excessive equipment and time and is not applicable to mass production of a portable test kit. The disclosure states a highly specific test for both Opium and heroin. However, Chloroplatinic acid is a broad spectrum alkaloid detection reagent capable of detecting over the counter prescription amine products and Cobalt thiocyanate will produce positive indications with alkaloids and cocaine products, so it is highly unlikely to be specific and minimize false positive presumptive indications.
Another example, U.S. Pat. No. 5,457,054 discloses a broad spectrum detection method for illicit drugs including Heroin, consisting of preparation of stock solutions of Cobalt thiocyanate, Ammonium metavandate and yellow food coloring in methanol, immersing a woven pad into the said solution and hermetically sealing said impregnated pad inside ethylene-acrylic acid copolymer/aluminum foil/polyethylene/paper sachets ready for use. Presumptive identification of Heroin is indicated by development of a green hue.
U.S. Pat. App. No. 20110151570 discloses the use of Spectral Fluorescence Signature technology of residues in acidic solutions for the differentiation of Morphine from Heroin.
U.S. Pat. No. 3,972,992 discloses a method for the presumptive identification of Opium alkaloids utilizing amino lower alkyl ethers of the phenolic hydroxyl groups of opium alkaloids, which are linked via a peptide linkage to carboxylated latex polymers, forming reagents useful for detection of opium alkaloids in body fluids.
U.S. Pat. No. 4,840,912 discloses a method for presumptive Heroin identification which utilizes adsorbent pads impregnated with solutions of Picric acid and Anthracene. The wet impregnated pad must be packaged in highly specialized inert backing material and then a specialized glue applied around the edge of the backing and a hydrophobic blocking layer cover applied to form a type of sachet. The disclosed methodology utilizes hazardous, explosive reagents, and specialized packaging materials and equipment, none of which allows extremely cheap, mass production possible.
Deakin, A., [7] investigated various liquid acid reagents, including hydrochloric, sulfuric, nitric, and acetic acids to both enhance detection and reduce false results when using a modified Cobalt thiocyanate spot test for the detection of Cocaine free base. Said documented procedure requires a laboratory setting and equipment, reagent preparation and multiple steps to complete a single test.
Similarly, U.S. Pat. No. 3,955,926 discloses a method for broad drugs of abuse screening and identification, including Cocaine, which is detected by dissolving suspect residue in dilute acid acetic acid containing a Cobalt(II) chloride and then applying a small aliquot of said solution to an absorbent support impregnated with ammonium thiocyanate. In its disclosed format, Part A of said device requires liquid reagents and Part B comprising extremely hygroscopic ammonium thiocyanate impregnated into a solid bibulous carrier which will remain wet. The moisture content of said bibulous carrier would effectively prevent efficient kit manufacture and packaging and reduce kit reactivity with time.
U.S. Pat. No. 4,320,086 discloses a method for detection of Cocaine type stimulants which utilizes a bibulous carrier impregnated with an aqueous solution of Cobalt thiocyanate and Phosphotungstic acid dissolved in 50 ml water; then 50 ml anhydrous methanol are therein mixed. Impregnated sheets are air dried and cut to suitable size. Detection is achieved by applying a few milligrams of suspect residue to end of wetted finger and rubbing onto impregnated carrier. The disclosed method of device manufacture is very labor intensive and time consuming.
In another example, U.S. Pat. No. 4,812,413 discloses an aerosolized spray reagent kit for the detection of Cocaine type stimulants, based on a modified Scott's reagent. The modified reagent consists of an aqueous solution of Cobalt thiocyanate, combinations of polyols including glycerine and propyleneglycol, and various emulsifying, antifoam and inert pressurized gases. The disclosed device is a specialized and costly manufacturing process. The packaging is costly and adds greatly to downstream rubbish disposal. Users are exposed to aerosolized reagent particles and spray drift.
In a further example of a modified Scott's reagent, U.S. Pat. No. 5,753,513 discloses a reagent solutions consisting of Cobalt thiocyanate, a polyol chosen from a group consisting of propylene glycol, 1,3-propane-diol, 1,4-butane-diol, ethylene glycol, poly-ethylene glycol (PEG) 200, PEG-400, PEG-600, diethylene glycol mono ethyl-ether, poly-propylene glycol (PPG) 200, PPG-400, and PPG-600 and an acid solution chosen from acetic, hydrochloric, citric and, or phosphoric acids. The reagent solutions are provided in bottle containers.
In yet another example of a modified Scott's test, U.S. Pat. No. 6,133,040 discloses a method of introducing an additional reaction step for presumptive identification of Cocaine type stimulants involving reaction with an organic solvent solution of pH phthalein indicator. Here again the test kit consists of many bottles of various hazardous liquid reagents and is more suited to a laboratory setting.
Impregnation of bibulous carriers with reagent solutions is an incredibly inefficient and costly method of presumptive test kit manufacture. Ultimately, the solvents used to dissolve the powdered reagents must be removed by evaporation. Often the solvents will be aqueous based and acidic in nature, which makes removal from the bibulous carrier hazardous, very costly, and will require very sophisticated laboratory equipment to minimize exposure and corrosion of the surrounds. In the event that the bibulous carrier can be dried, it must still be cut and presented in a kit format for ease of use. Often, this will incorporate plastic injection molded housings, which are magnitudes of order more expensive than paper based supports. Additionally, the cost of the injection die is excessive. The alternative low cost paper based solid support carrier option for a presumptive kit is often not possible, as the loaded bibulous carrier strips resist sticking and adhering to common pressure sensitive adhesives because of interaction with the impregnated reagent(s) and/or the pressure sensitive adhesives react with the impregnated reagent(s), destroying the kits.